Plenity, a non-systemic, FDA-cleared oral hydrogel designed to mimic the properties of raw vegetables, showed responders to treatment lost ~9% of their body weight over 6 months and over 85% of overall patients lost weight, consistent with previous clinical studies

Patients with a self-reported poor diet quality at baseline were the ones most likely to have a meaningful response to therapy and the majority of people reported they had not improved their diet or exercise during treatment

Plenity has the potential to be a weight loss solution for a broad population given the treatment’s wide label, affordability, and excellent tolerability profile

Gelesis, the maker of Plenity for weight management, presented a late-breaking poster presentation at the American Diabetes Association’s (ADA) 2023 annual meeting showing the real-world effectiveness of the company’s oral superabsorbent hydrogel across 894 people who were prescribed Plenity for weight management. Consistent with previous clinical studies, responders demonstrated clinically significant weight loss at 6 months.

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Plenity is a non-systemic, FDA-cleared oral hydrogel designed to mimic the properties of raw vegetables. (Photo: Business Wire)

Plenity is an orally administered, non-stimulant, non-systemic aid in weight management based on proprietary hydrogel technology with a highly favorable safety and efficacy profile demonstrated in both clinical studies and real-world evidence. It is indicated to aid weight management in adults with excess weight or obesity, a Body Mass Index (BMI) of 25–40 kg/m², when used in conjunction with diet and exercise.

“It is an exciting time where the conversation around treating excess weight and obesity is finally shifting to recognize the need for many forms of treatment. Not one treatment fits all, even GLP-1 agonists, and a need remains for multiple tools and in particular weight management therapies that are accessible, affordable, and clinically proven,” said Elaine Chiquette, Pharm.D., one of the study’s authors. “Interestingly, data from this large sample size suggests the people who are most likely to succeed on Plenity are those who reported having a poor quality diet which is consistent with the hypothesis that Plenity works by emulating the effects of a large volume of raw vegetables. Here is a treatment option for people including those who may be struggling to make those changes to their diet.”

The retrospective analysis presented at ADA examined chart records of 894 patients from national telehealth platform Ro, which provided structured, online visits for weight management. The mean pre-treatment BMI was 31, and the patients were mostly female with a mean age of 50. About 35% of people had overweight (pre-obesity) and no other comorbidities.

After 6 months of treatment, about 86% of patients reported weight loss, and among treatment responders, the average weight loss was approximately 9%. Notably, the majority of patients reported they had not made additional improvements to their diet or exercise, and in fact, people with self-assessed poor baseline diet quality were more likely to have a meaningful response to therapy. Most patients (70%) reported adhering to treatment at least four days per week. The findings of the study suggest that Plenity could help address an ongoing need in weight management, even for patients at the lower BMI range of overweight and obesity who are struggling to change dietary habits.

About Gelesis

Gelesis Holdings Inc. (“Gelesis”) is a consumer-centered biotherapeutics company and the maker of Plenity®, which is inspired by nature and FDA cleared to aid in weight management. Our first-of-their-kind non-systemic superabsorbent hydrogels are made entirely from naturally derived building blocks. They are inspired by the composition and mechanical properties of raw vegetables, taken by capsule, and act locally in the digestive system, so people feel satisfied with smaller portions. Our portfolio includes Plenity® and potential therapies in development for patients with Type 2 Diabetes, Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional Constipation. For more information, visit gelesis.com, or connect with us on Twitter @GelesisInc.

Plenity® is indicated to aid weight management in adults with excess weight or obesity, a Body Mass Index (BMI) of 25–40 kg/m², when used in conjunction with diet and exercise.

Important Safety Information about Plenity

• Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity.
• To avoid impact on the absorption of medications:
  • For all medications that should be taken with food, take them after starting a meal.
  • For all medications that should be taken without food (on an empty stomach), continue taking on an empty stomach or as recommended by your physician.
• The overall incidence of side effects with Plenity was no different than placebo. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence.
• Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor.

Rx Only. For the safe and proper use of Plenity or more information, talk to a healthcare professional, read the Patient Instructions for Use, or call 1-844-PLENITY.

Forward-Looking Statements

Certain statements, estimates, targets and projections in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws. The words “anticipate,” “believe,” continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding Gelesis’ or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to Gelesis’ expected operating and financial performance and market opportunities. In addition, any statements that refer to guidance, projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Gelesis assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Gelesis gives no assurance that any expectations set forth in this press release will be achieved. Various risks and uncertainties (some of which are beyond Gelesis’ control) or other factors could cause actual future results, performance or events to differ materially from those described herein. For a description of such factors, please see the section entitled "Risk Factors" in Gelesis’ most recent Annual Report on Form 10-K and in other filings that Gelesis makes with the Securities and Exchange Commission. These filings address important risks and uncertainties that could cause actual results and events to differ materially from those contained in the forward-looking statements.

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